CA1055351A

CA1055351A - Securement device for intravenous catheter and its tubing

Info

Publication number: CA1055351A
Application number: CA225,515A
Authority: CA
Inventors: Philip M. Buttaravoli
Original assignee: E-MED CORPORATION
Current assignee: E-MED Corp
Priority date: 1974-05-03
Filing date: 1975-04-25
Publication date: 1979-05-29
Also published as: US3918446A; JPS50152582A

Abstract

ABSTRACT OF THE DISCLOSURE
A device for securing to the skin and protecting an infusion needle or catheter in the body portion of a Patient and for holding a portion of the excess tubing while providing a cushion between the catheter-tubing assembly and the skin, consisting of a bottom pad and an associated upper pad, both pads being formed of flexible material.
The bottom pad is provided with at least one slit extending inwardly from one edge and terminating in an enlarged perfor-ation comprising a medicament well. A first portion of the upper pad is affixed to the bottom pad and a second portion of the upper pad constituting a flap may overlie the slit and well in the bottom pad. Means are provided to removably affix the second portion of the upper pad to the bottom pad and to affix the bottom pad to the skin of a patient.

Description

~0553S~

1. Fleld of the Invsntlon The pre~ent ln~entlon relat0a generall~ to th2 medical fleld and more particularly to ~ de~lce Yor ~ecuring and protectlng an ln~ualon needle or oatheter and for holding a portlon o~ the exoess tublng while provld.ln6 aoos3~ to and observation of the catheter and tubing durlng the l~tra-venou6 infusion.

2 . Deeorlptlon of the Prlor Art Intra~enou~ ~eedin~ and tranaru~ion~ ara among ~.
the mo~t ~requentl~ acoompli3hed and e~sentlal treatmente o~ :.
~eriously in~ured or 111 patient~ in ho~pitals. Infuslon apparatu~ employed ln the intravenoua ~eedl~ o~ ~lood, plasma, gluoose water, ealt water, and the like inoltlde~ ;
an lnfu~lon needle or cabhetar, a handle portion, and Q
length Or tubln6 oonneoting th0 needl~ to a aource o~ lntra-venous fluld. In ¢onven~ional practice, the n~edle or catheter is lnserted lnto the ~ein of the patient and co~straln0d in ~uch ~ositi~n ~y small ~trips Or adhesive t~p0 colmected ~o the handle ~o ~hat the needle or oa~heter will b~ seourad to the ekln and not fall or be pulled out. The punoture site of the needle or oatheter i8 o~tsn protected with an anti-bacterlal ointment and/or a ~auze pad for the purpose of halpln~
to lower the ohance of lnfectlon. Th~ 6auze pad also ~er~e~
as a ¢ushio~ if pl~o~d under the catheter and handlo portion.
Whether or not the antibacterial ointme~t and/or gauze pad 10 s.ppll~d, ths needle or oatheter, alo~ wlth th0 tubing" i5 commonly seourod to the ~kin or body portlon of the pa~ierlt wlth ee~eral ~trip~ o~ adhesiYe tape. A portion o~ the exoe~
30 tubing 1~ then u~ually ooiled olosely adJa~2nt to the needle ~, .

~15S35~

or ca~heter and 1~ held ln place by several addltlonal ~trips of aahesi~e tape ov0rl~1ng the entlre ~truoture~ The purpose Or this coll i~ to absorb an~ unexl~cted ~udden tenslon plaoed upon the remainder of the tubi~g (as with aooidentally belng pulled upon) wlthout dl~turblng the c athet er.
This prooedure pose~ se~eral problsms; namelg, 1) the accumulation o~ ~everal item~ ~le.gointment, gauze pad & tape) into one convenient locatlon; 2) the sep~rate applicatio~ Or these ltem~ at the time o~ lnsertlon Or the lnru~ion needle or oatheter; 3) the ne¢e~slty o~ tearin~
multlple ~trl~s of tape often o~ varylng length~ and wldth3;
4) the lndlvidual appllcation of eaoh strip Or tape over the in~uslon needle or cathster and tubl~g to seoure them to the ~kin or bod~ portlon Or the patient and to provid~ a "U"-shaped loop in the tublng to allow ~or a sudden pull on the tubing wlthout allo~lng the needle or catheter to b~ dislodged; -:
5) the re~ultant pres~ing of the hub o~ the needle or catheter and tublng agaln~t the skin or bod~ portlon o~ the patie~t :.
whioh can cau~e discomfort and actual skin damage unl~ss a cushlon is provlded; 6) the dlrficult and time consuming ta~k of havlng to remove each plece of tape oare~llly and lndlvld~ally when and i~ the needle or catheter need~ to be lnapected wlthout dislodging the needle or catheter; and 7) the lnability to malntaln the sterilit~ o~ the aboYe msntioned items.
While man~ prlor art securement device~ and tha llke ~ :
ha~e endeavored to allevlate ¢ertain o~ th~ a~oremsntloned : :~
probl~m3, for one rea00n or another the~ have generall~
~roven to be un~a~s`~actor~. ~u¢h prlor art devlcea known to ~0 applican~ are: U. 3. Pat. Noe~ 3,046,989 Hill; 2~159~g47 ~a~sel;

, ,~ . . ~: ., '' 5535~

2,402,306 Turkel; 2,669,231 Fisher. 2,814,294 Figge;
2,898,917 Wallace; 3,046,984 Eby; 3,059,645 Hasbrouck;

3,138,1S8 Gordon, et al; 3,146,778 Krawiec; 3,286,713 Kurt~, et al; 3,367,332 Groves; 3,422,817 Mishkin; 3,430,300 Doan;
3,461,869 Hargest; 3,542,321 Kahabka; 3,613,663 Johnson;
3,630,195 Santomieri; 3,670,727 Reiterman; 3,677,250 Thomas;
3,683,911 McCormick; 3,724,456 Waxman; 3,726,280 Lacount;
and 3,782,378 Page.
SUMMARY OF THE INVENTION
According to the present invention, the afore-mentioned problems are solved by providing an improved device for securing and protecting an infusion needle or catheter of a variety of dimensions and configurations in the body portion of a patient to the skin and for holding a portion of the excess tubing in a "U" shaped loop while providlng a cushion between the catheter-tubing assembly and the skin.
This invention relates to a device securable to the skin of a patient for holding in place and protecting an infusion needle or catheter in the puncture site of a body portion of a patient and for holding a portion of the excess tubing while providing a cushion between the catheter tubing assembly and the skin, which comprises top and bottom pads, ;~
said bottom pad being formed of flexible material having ` upper and lower surfaces and having at least one slit extending from one edge inwardly of said bottom pad to a termination point within the confines of said bottom pad; means to affix the lower surface of said bottom pad to the body por~ion of the patient; said upper pad overlying said bottom pad and being formed of flexible material having upper and lower surfaces, a portion of the lower surface of said upper pad being affixed to a portion of the upper surface of said bottom pad, said portions forming a line of juncture dividing said bottom pad ..
_ 3 -~ q ~ ~ ' ;.: . .. : :
.:: . : , ~6~5S3~
into first and second parts and sald upper pad into first and second flaps overlying said Eirst and second bottom pad parts, respectively, said one slit being located in one of said bottom pad parts; and means to releasably afEix substantially the lower surface of said first and second flaps of said upper pad to the upper surface of said first and second bottom pad parts, respectively, whereby in use said slit cradles the infusion needle or catheter and substantially surrounds the puncture site, protecting it from bacterial infiltration, one of said flaps overlying said slit and with said slit and said line of ~ -~
juncture securing the infusion needle or catheter and the tubing behind it over an extended length to secure against ~ ;
lateral and longitudinal movement, and the other of said flaps serving to cover and hold an additional loop portion of the tubing against one of said bottom pad parts to provide a safety loop of the tubing, thereby insulating any shock to the tubing `;
transmitted by the infusion needle or catheter.
Briefly, in its broadest form, the improved securement device includes a bottom pad formed of flexible material having upper and lower surfaces and at least one slit extending from one edge inwardly of the bottom pad and preferably terminating in an enlarged perforation comprising a medicament well. Means are provided to affix the lower surface of the bottom pad to -the skin or body portion of the patient. An upper pad, also ~
~. .
formed of flexible material, is also provided. A first portion of the lower surface of the upper pad is affixed to the upper surface of the bottom pad. The upper pad is also provided with a second portion constituting a flap which may overlie the slit and enlarged perforation comprising the medicament well.
Finally, means are provided to removably affix the second portion of the upper pad to the upper surface of the bottom pad.

... .. . . . . .

~S~3Sl In a ~rer0rred embodiment ~ the bottom ~ad ~
provided with two sub~tantially parall~l ~llt~ extendlng ~rom the same ed~o, wlth each ~lit termlnatine; ln th~ aforementioned enlar~d perforatlon, and the flr~ ~ortlon o~ the lower ~urfaoe Or the u~per pad i~ af~lxad to the upper ~urrace Or the bottom pad along the central portion thereo~ b0tween the 811~g, creatlng two flap portions. In practlce, one o~
the flaps ser~e~ ~o oover the porforatlon belng used and the other o~ the flap~ is used to hold an addltional portion o~ the t~be. The two ~lit~ ~ive the o~erator an option Or slidlng e1thar one or the other 811t around the intravenou~
¢atheter, thereby allowlng the o~erator to po~ltion the bottom pad on the most ~ropitlous area o~ the body portion of the patient ~ie. on the dor~al rathor th~n the ventr~l ~ur~aae of the rorearm to avold re~tin~ the pad on ~he bed sheets while the patlent rest~ ln a prone ~o~ltlon).
In stlll another embodiment of the invention, th0 bottom pad lncludes two sllte extendlng from opposit~ edges thereof lnwardly~ with eaoh 81it t~rmlnatin~ ln the afore-mentloned ~nlarged per~oratlon. The u~per and lower pads are integral at mating edge B thereor.
The impro~ed ~eourement de~ice o~ the pres~nt inventlon overcome~ all o~ the aforem0ntioned and sPecirloally enumerated ~robleme in connection wlth the prior art procedur~
for attaching an intravenou~ needle or catheter to the skln of any body port ion Or a pat ient .
'.

FIG . 1 i 8 a par~ ially exploded view o~ one embodi ment of the ~ecurement device oi~ the ~re~ent lnvention.
FIG~ 2 1~ an end view o~ the seourement de vice o~
FIG. 1.

~O~iS3~ :

Figures 3 through 8 are perspective view showing how the securement device of Figures 1 and 2 is placed on a body portion of a patient.
Figure 9 is a plan view oE a secorld embodiment of the securement device of the presen-t invention. ;
Figure 10 is an end view of the securement device of Figure 9.
Figure 11 is an end view of the securement device of Figure 9 in the closed position.
Figure 12 is a perspective view showing how the secure-ment device of Figures 9 through 11 is placed on a body portion of a patient. ~
Figure 13 which appears on the second sheet of drawings ; , with Figure 8 is a series of enlarged view showing exemplary end enlarged perforations which may be used with the securement devices of the present invention.
Figure 14 is an enlarged view showing a large notch on ~
the side of a bottom pad, with associated slits extending there- ;
from, which may be used with the securement devices of the present invention.
DESCRIPTION OF THE PREFERRED EMBODINENTS
ReEerring now to the drawings, wherein like parts are designated with like numerals throughout, and more particularly to Figures 1 and 2, one embodiment of the improved securement -device of the present invention is designated at 10. As can be seen, the securement device 10 includes a bottom pad 12 and an upper pad 14, both formed of flexible material, and preferably of suitable polyurethane foam material.
The bottom pad 12 is provided with at least one slit 16 extending from one edge 18 inwardly of the bottom pad 12 and terminating in an enlarged perforation 20 comprising a medicament ,: - . - : .

~5535~
well for lntment or encapsulated ointment 22, which may be included in the pad 12 or may be placed in the perforation 20 separately during - 5a -:, . . . . . .

~05535~

appllcation of the pad 12 to the skin, a~ will be moro ~ully explained hereinafter. The alit 16 preferably wlden~, such a~
in ~-notoh ~ashion 24, at the cdga 18 to ~orm a lead-ln portion.
Tha lower ~urfaoe 12b and 14b o~ the bo~tom and upper pad~ 12 and 14, re~pectivel~, are each provlded with an aaheslv~ material 26, which 1~ e~a~erated 1~ th~ drawlne~ ~or purpo~es o~ olarlty Or illu~tratioll. The adhe~ive material 25 will pre~erably contain a baoterioatatlc or bacterlocidal ~ ~:
ohemical to arresk the growth of or ds~tro~ any organism~
10 pr~sent in deep pore~ or 3weat ~land~ or hair ~olli¢les of the ~kin ~ur~aoe o~ the body portion o~ the patlent and ~e¢urement : . . .
devlce. Fu~thePmor~, the ointment 22 19 antibiotio; ~or example olntments ~uch a~ are presentl~ 301d under khe trade~
marks Polysporin or ~etadine, and the bottom and up~er pads .;~
12 ana 14, ir made o~ foam, may be ~teriliz~d and al~o oonkain '~ a bacterlo~tatl¢ or bacteriocidal chemioal. Thus, baoterla are pre¢luded ~rom reaohing the inel~lon throu~h or u~der the ~ecurement deYice lO or along the lnfuaio~ needle or cathster, and those whioh may be pre~ent are de~tro~ed. The lncl~ion iB thereby insulated from~'a maJor ~ouroe o~ inrection by a physioal barrier lr not a cheml¢al one~
A removable backin~ ~heet 28 o~ paper, plastic or the like 18 prererabl~ maintain~d in contact wlth the adhesive ~ material or coating 26, on the lower surfa¢e 12b~ 14b of the :', 25 bottom and upper pad~ 12 and 14, re~pectiv61~. Th~ removable backing sheet 28 al~o pr0~er~bly ha~ at leas~ one expo~sd ~ and ea~ily acce~31ble portlon 30 to enable lt to be readil~
:I removed. For ex~mple, this may be aocompli~hed by roundi~g i the corner~ 12c and 14c of the bo~tom and upp~r pade 12 and 14, re~pect~vely, whlle maintaining the corners 28a of the remo~abls backing ahee~ 28 in a equare con~lguration, ~5S3Sl The ~ecuremen~ device 10 Or ~IG~. 1 and 2 ma~ be packaged and ~hlpped as two ~eparate pad~; namely, the bottom and u~Par pads 12 and 14 a3 previou31y described. However, lt has been ~ound preferable to sever the removabl~ backing 3heet 28 o~ the u~per ~ad 14 lengthwise in two parallel leneths definlng a ~trlp substantially at the mld-~oiht thereof and to remove thls ~trip of backing sheet 28 ~o as to expose a first portion 34 on the lower surf~ce 14b o~ tho upper pad 14. The ~ir3t portlon 34 o~ the lower surfacQ 14b Or ths upper pad 14 i~ then a~fixed to the central ~or~lon 36 of the upper ~urrace 12a o~ khe bottom pad 12 80 a9 to form two ~laps 38 and 40, eaoh o~ whlch may overhang an - ed~e 19 and 21 of the botkom pad 12.
Ir desirable, perforatlons 42 may be inserted through the rla~ 38 and 40 for purpose3 Or in~pectlon Or the inrusion needle, tublng and the like, and ~or inJectlon o~ further medlcation at a sub~equen~ time into the tublng or intra~enou~
~eedin~ e.
A rabric or other ooating 32 ~ay be placed on the ~ ~;
uppar surface 12a o~ the bottom pad 12 to allow ~or a rever~ible adhe~ion between the bottom of the flap~ 38 and 40 and the u~per surfaoe 12a of the bottom pad 12.
A label 44 may be a~lxe~ to the upper ~ur~a¢e 14a Or the upper pad 14 between the flaps 38 and 40 to enable medlcal personnel to indicate th~reon the t~e o~ intravenoua needle or catheter, the ~ze of ths ¢atheter and the date ~nd ti~e th~ in~usion needle or ¢atheter was inserted.
Turning now to FIGS. 3 through 8, tha applicatlon of the ~ecurement device 10 of FIG~. 1 and 2 will now be explained~ A~ ca~ be seen, a velnpuncture 1~ made ln the arm .

1~553S~L

or other suitable body portion 46 by penetrating the rle~h and vein tnot ~ho~m) wlth a hol~ow lntravenou~ needle or catheter 48 as ~hown in FI~ he infu3ion tube 50, which 1~
connec1ied to the needle or cathoter 48 by the cou~lin~s 5~, la adapted to be coupled to a eource ol` infu~lon liquid (not ~hown). These arorementloned items all ~a:ry ~ome~hat in 3ize, -:~
shape, and configuration from one manufacturer to another.
A~ter the in~u~ion needle or catheter 48 i~ ~atlsfaot-', .:
; orily inserted ln a vein, the approprlate portion of th~ bottom pad 12 with the ~ost deslrable ~ 16 1~ cho~en ~o ~8 to offer the most ad~antagoou~ posi~ion of the pad 12 on the patien~ 1 8 bod~ portlon. At this polnt, it should be empha~ized that any slit 16 of the pad 12 may be utilized. The removable ba¢king ~heet 28 from the seleoted side of the bottom pad 12 18 then removed. The rlap portlon o~ the associated upper pad 14, such ae the flap 40, i~ then ~olded back and the ~lit 16 le carerull~ ~lld around the lnnu~ion needle or ¢atheter 48 : -until the skln punctur~ slte ie surrou~ded to the well 20 ;~ :.
at the e~d of the 811~ 16. The halr o~ the ba~e or bottom pad 12 havlng the sllt 16 being used i8 then pressed ~ecurely against the skin of the bod~ portion 56 of the paliient, ; ~uoh that this half of the base pad 12 ie a~flxod to the body portlon 56 by means of the adhesive 26. If ointment 22 i~
not already present in the well, i~ may be in~erted at thl~
. 25 timeO
As shown in FIG. 4~ aM er the base pad 12 i8 properl~
positloned with respect to the inci~io~ and the infu~ion needl~
or oatheter 48, the ba~king shee~ 2~ 1~ remo~ed ~rom the upper :~
~lap or wlng 40, and the flap 40 1~ pre~ed down ov~r the lnfuslon ; 30 needle or oatheter 4R~ and the lower ~ur~ace 14~ 9 with the , ~

~ ~ 5 S 3 5~
adhe~lve material or coating 26, i8 re~ovably or permanently afflxed to the upper surface 12a of ~he bottom pAd 12, as shown ln FIG. 5. Accordingly, th0 infu~ion na~dle or catheter 48 19 ~andwlched between the lowar ~urfaoe 14b and the upper ~ur~ace 12a o~ the u~par and bottom pads 14 and 12~ r~speotlvely.
The removabla backin~ ~heet 28 i~ then removed rrom the bottom or baae p~d 12 on the adJolning unu~ed aid~3, and pre~sed against the ~kin or body portion 56. The infu310n tube 50 i~ th~n looped around, and po~itioned between the upper ~ur~ace 12a of the ad~olnln~ unu~sd ~ide o~ the base or bottom pad ].2 and the lower ~ur~ace 14b Or the unused wing or ~lap 38, ignori~g the remalnlng 81i~ 16 and as~ociated per~oration 207 as best ~een ln FIG9. 6 and 7. The baoking aheet 28 1~ then re~o~ed rrom the lower sur~aGe 14b Or the wing or flap 38, and the wln~
or flap 38 ia ~ressed down over the in~u~ion tubin~ 50, sandwlchin~ the tublng 50 between the lower ~ur~ace 14b o~ the ~lap 38 o~ the upper pad and the upper sur~a¢e 12a o~ the base or bottom pad 12.
; A~ can be seen, the ~ull ln~usion llne 5Q and the head of the inrusion needl~ or oatheter 48 may be cheoked or in~pected by ll~tlng the wing~ or ~lap~ 38 and 40 of the upper pad 14. The wings or ~laps 38 and 40 may then be repoeitione~
over the in~ualon tublng 50 and in~u~ion needle or cathet0r 48 ~or oontlnued seourement. Any ~hock to the infuelon llne 50, such a3, ~or example, b~ patient ~ull and the like, wlll be ab~orbed by the ~ecurement deYiCe 10 in an area whlch ia i~olated ~ :
:f rom the head o~ the inru~ion needle or catheter 48. In thi~
way pullin~ upon the in~uslon llne 50 w111 not cau~e the infuslon ne0dle or oatheter 48 ~o ba dl~turbed. I~ will, Or cour~e, be 3een that the ~curemsnt device 10 o~ the pres0nt - :- - , . . . .

~535~
inventlon will readlly accspt infuslon needl~s or cathoters 48 of ~arying ~lzes and oonfi~urations.
It wlll, of cour~e, be Been that the entlre head o~ ths infu~ion needle or catheter 48 18 covered ~o that it can not be disturbed, or moved, either by ~atient 3arring or dlsr~tio~ b~ a ~orelgn obJect or force. Furthermore, the lncision area i9 contlnuously ~rotected by the securement deYice 10 from any expo~ure to bacteria ancl the like.
It wlll be seen that the ~ecurement device 10, a~ de~¢ribed ln connectlon wlth FIGa. 1 and 2, and a~ sho~n ln oonnectlon wlth FIGS. 3 through 8, whe~ app}ied to the body portion 56 o~ a patlent, overcome3 the aforementioned ~hort ¢omlngs of prlor art devlce~. The securement device 10 elimlnates the aocumulation of 3everal item~, ~uch Q~, ointment ~i~ oint~ent 19 inoluded in the well 22), gauze pad and multlple tape ~trlp~ and lt ellmlnates the separate appllcation of thess items at the time o~ lnsertion of the infu~ion needle or oatheter 48. The neoesslty of tearing multiple strips of tape, often o~ varylng lengths and widths) i~ al30 eliminated, a~ iB the lndivldual appllcation o~ each ~trip of tape over the infusion needle or catheter 48 and the tubln~ 50 to secure these to the skin or body portion 56 and provide a loop 58 ln the tubi~g 50 to allow for Q ~udden pull on the tubing 50. In 80 doing, the resultant pre~sing Or the hub of the infusion needle or ¢atheter 48 against the skin or body port~on 56, which can cau~e dlscomfort and actual skin damage, i~ also eliminated~
The di~ficulty and time oonsuming ta~k o~ haYing to remove each piec~ of tape carefully and individually when and lf the infu~ion ne~dle or catheter 48 need~ to be inspected without di~lodgin~
the nesdle or catheter 48 iB al~o elimlnated. Finall~, this : . . .

~5535~ :
dsvice ma~ be p~ckaged ln a sterll~ condition which also ~rotecte the patient ~rom the haz~rd~ Or ~otentially contamlnated rolls of tape.
FIG~ 9 di~closea a ~urther embodiment 60 o~ the seourement devioe o~ the ~reeent lnventlon. A~ can be ~een9 the securement devlce 60 comprlses a baee or bottom pad 62 -and an u~per p~d 64, the pads being lnte~srally hlnged at 66 alone the m~ting ed~e~ 68 and 70, re~p~ctively.
The pads 62 and 6~ are ~ormed of ~lexible material, preferably o~ polyurethana ~oamJ and the upper pad 64 ~a~ be Or suoh dimen~ion aa to overhan~ at leaat one edge o~ the botto~ pad 62, a~ at 72.
~ rhe lower ~ur~aoe 62b of the base pad i8 providsd wlth an adhe31ve materlal 63 adapted to af~lx the lower aur~ace 62b of the base pad to the skln or body portion Or a patient.
The upper sur~ac~ 64a of the upper pad 64 1~ pro~lded wlth an adhesi~e 65 such that the upper pad 64 may be folded over and a~rixed to the upper surface 62a of the ba~e pad 62. The upper surrace 62a of base pad ~2 may b0 co~ered with a cloth or pla~tlc aur~ace su¢h as 1 shown at 67, to assist in the removabilit~ o~ the upper aur~ace 64a of the upper pad 54 ~rom the upper surface 62a of the base pad 62 onoe it i8 adhered to the ba~e pad 62. As hereinbsfore explained, the adhe~ive material 63 and 65 i8 pre~erably antlbacterlal in that it po99e8~e8 baotsriostatlc or bacterio¢idal proper~ies whlch enable lt to arre~t the growth o~ or d~stroy ~ny organism~ :
pre~ent in deep pores or sweat glands or hair ~oll~cle~ o~ the ~kin ~urfacs and 3ecurement device 60. Thu~, bacteria are preoluded ~rom reachine the inci~ion through or under the securement device 60 or alon~ the in~u~ion needle or cathet0r ' 11 ' , . :; - : ~.

` ~ .

~0553~
by p~ysical if not chemlcal means. It wlll, of cour~e, be obvious that ths thickne~ of the adhe~ive matorlal 63 and 65 1~ exag6erated ln the dra~lngs rOr clarlty of illustration.
The baae or bottom pad 62 i9 pro~rid~d with ~llt 76 extendlng from opposite edg0s 78 and 80 inwardly o~ the bottom pad 62~ wlth ea¢h slit 76 terminatirle; ln an enlarged per~oratlon 82 comprisi~K a medicament well. The well 82 ma~ hold ~ultable ointment or encap~ul0d ointment 84. The :
slits 76 prererably wlde~, ~uch a~ ln V-notch fa3hlon 81, at the opposlte edges 78 and 80 to form lead-in portions.
A~ indloated in ¢onnectlon with the embodime~t o~
FIG~. 1 and 2, ~uitable removab}e backing sh~et 86 of plaatlo, paper or the like may be malntained in contaot with the adhe~ive materlal or coating~ 63 and 65 to prevent the ooatings rrom lg beoomln~ attaohed to materlal other than de~ired prlor to the actual placement o~ the device 6Q around the in~u~ion needl~
or oatheter~
In operation, the baoking ~heet 86 is removed ~rom ~:
the lower aurfa~e 62b o~ the bottom or base pad 62 and the mo~t desirable slit 76 i~ slid arou~d the infu~ion needle or catheter 48 to th~ enlarged perroration 82 at the end of the sllt 76.
~he ba~e or bot~om pad 62 i8 then ~re~ed ~ecurely again~t ; the ~kin or body portion 56 of the patient, thereby belng a~fixod to the 3kln or body ~ortion 56 b~ ~eans o~ the adhe~lvo 6~.
The backi~g ~heet 86 i~ then removed from the upper ~urfa¢e 64a o~ the upp~r pad 64. The lnfusion tubln~ 50 i~ ;
loopod around, and position~d on ~h~ up~er eur~ace 62a o~ the bottom pad 62, artsr whlch time the upper pad 64 i9 folded over about the hin~e 66 and ~ressed down over the in~u3ion '.

.

1~)553Sl tubing 50 and infu~lon needle or cath2ter 48 and the up~er ~urrace 6~a of the bottom pad 62.
I~ ulll, of cour~e, be readily ~een that the ~e¢urement de~ice 60, a~ de~cribed ln oonnectlon wlth FIG. 9, elimlnate~ th~ aforementloned di~advantagels in oonneotion with the prior art as readily a~ the ~ecurement device 10, a~ :
described in connect lon wlth FIGS . 1 throu~h 8~
Turning now to FIG. 13, it will be ~een that A, B
and C thereor di~close ~arious enlarged per~oratlons9 88, 90 and 92, each wlth an a~soolated elit 949 96 and 98, ln the bottom pad~ 100, 102 and 104, respectively, whloh may be satisfa¢tory wlth the securin~ devlces 10 and 60 o~ the pr~sent lnvention. D, E, F and G o~ FIG. 13 show other modi~ications whereby only a per~oration, a~ at 106 and 108 in the ba~e ; 15 pads 110 and 112 o~ D and E, respeotiv~ly, or only a slit, .
; as at 114 and 116 ln the base ~ads ~18 and 120 Or ~ and G, respectl~ly~ may be ~ati~factory with the ~ecurin~ device~
10 and 60 Or the present lnvontlon.
While ~e~eral o~ the 3peolflo embodiment~ of the eecurement devioa of the present invention have been shown and deAorlbed, it will be apparent that varlou~ modi~ioation~ m~y ~ ;
be made therel~ without departin~ from the scope of the ln~ontion. Suoh modl~lcatlon~ in¢lude the formin~ Or a ~ .
~eourement devlca wlth th0 ba~e and upper pads aa separate ~ ~:
parts, or as inta~ral, the proYi~ion of an adhesive material or ooating on less than the en~ire lowor surrace3 Or the pads and th~ ellminatio~ Or removable sheet 8 i~ ~ound de~irable, or the use of an additlonal layer of a fabri~ or ~uitable material ln the upper ~ur~aee o~ the bottom pad~ to ln3ure the removable nature o~ the upper pad a M er it i8 a~ixed to the bottom ` ~SS351 pad, or an upper pad covsri~g le~e tha~ the full dlmen~lon of tha lower ~ad. Additlonally a~ s~own in FIG. 14J the ~-notch lead-ln portion3 122, each with an associated sllt 124 and enlar~ed per~oratlon 125, may extend inwardly from a lar~e notoh 128 on the ~lde 130 of a bottom pad 132.
~ariations in the features o~ the invention are set forth in the ~ollowing claims. ;:

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, ~` :
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, , : 14 .

Claims

1. A device securable to the skin of a patient for holding in place and protecting an infusion needle or catheter in the puncture site of a body portion of a patient and for holding a portion of the excess tubing while providing a cushion between the catheter tubing assembly and the skin, which comprises top and bottom pads, said bottom pad being formed of flexible material having upper and lower surfaces and having at least one slit extending from one edge inwardly of said bottom pad to a termina-tion point within the confines of said bottom pad; means to affix the lower surface of said bottom pad to the body portion of the patient; said upper pad overlying said bottom pad and being formed of flexible material having upper and lower surfaces, a portion of the lower surface of said upper pad being affixed to a portion of the upper surface of said bottom pad, said portions forming a line of juncture dividing said bottom pad into first and second parts and said upper pad into first and second flaps overlying said first and second bottom pad parts, respectively, said one slit being located in one of said bottom pad parts; and means to releasably affix substantially the lower surface of said first and second flaps of said upper pad to the upper surface of said first and second bottom pad parts, respectively, whereby in use said slit cradles the infusion needle or catheter and substantially surrounds the puncture site, protecting it from bacterial infiltration, one of said flaps overlying said slit and with said slit and said line of juncture securing the infusion needle or catheter and the tubing behind it over an extended length to secure against lateral and longitudinal movement, and the other of said flaps serving to cover and hold an additional loop portion of the tubing against one of said bottom pad parts to provide a safety loop of the tubing,thereby insulating any shock to the tubing transmitted by the infusion needle or catheter.

2. The securing device according to claim 1,wherein said slit terminates in an enlarged perforation comprising a medicament well.

3. The securement device according to claim 1, wherein said means to affix the lower surface of said bottom pad to the body portion of said patient comprises an adhesive coating on the lower surface of said bottom pad.

4. The securement device according to claim 3, wherein said adhesive coating is protected by a removable sheet prior to adhering the lower surface of said bottom pad to the body portion of the patient.

5. The securement device according to claim 4, wherein said releasable sheet has an exposed, easily accessible portion to enable it to be readily removed.

6. The securement device according to claim 1, wherein said means to affix the lower surface of said bottom pad to the body portion of said patient, and said means to releasably affix the lower surface of said first and second flaps of said upper pad to the upper surface of said first and second bottom pad parts, respectively, comprises an adhesive coating on the lower surface of said bottom pad and the lower surface of said first and second flaps.

7. The securing device according to claim 6, wherein said adhesive coating on the lower surface of said bottom pad and on the lower surface of said first and second flaps is provided with a removable sheet.

8. The securement device according to claim 1, wherein said upper pad is permanently affixed to said lower pad along said line of juncture.

9. The securement device according to claim 1, wherein said upper pad is integral and one piece with said lower pad along said line of juncture.

10. The securement device according to claim 1, wherein said first and second flaps overhang at least one edge of said bottom pad.

11. The securement device according to claim 1, wherein a second slit is provided in the other one of said first and second bottom pad parts extending inwardly of said bottom pad to a termination point within the confines of said bottom pad.

12. The securement device according to claim 2, wherein said bottom pad includes two slits extending from opposite edges inwardly of said bottom pad.

13. The securement device according to claim 2, wherein ointment is provided in said medicament well.

14. The securement device according to claim 2, wherein encapsulated ointment is provided in said medicament well.

15. The securement device according to claim 1, wherein said slit widens at said edge whereby to form a lead-in portion.

16. The securement device according to claim 1, wherein a large notch is provided on one edge of said bottom pad and said slit extends therefrom.

17. A securement device according to claim 1, wherein said line of juncture extends substantially parallel to said one slit.

18. The securement device according to claim 1, wherein said line of juncture is located along the central portion of said bottom pad.

19. The securement device according to claim 1, wherein said bottom pad parts are of equal width and said flaps are of equal width.